Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

Tekmira Provides Corporate Update and Announces Second Quarter 2013 Results



Tekmira Provides Corporate Update and Announces Second Quarter 2013 Results

Conference Call at 4:30 pm Eastern Time Today

VANCOUVER, British Columbia, Aug. 12, 2013 (GLOBE NEWSWIRE) -- Tekmira
Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of
RNA interference (RNAi) therapeutics, today announced its financial and
operating results for the second quarter ended June 30, 2013 and provided a
corporate update.

"I am proud of the progress we have made over the first half of this year, as
we focus on advancing Tekmira's pipeline of proprietary therapeutics. Earlier
today, we outlined our development plans for our TKM-PLK1 oncology program,
which will include two separate Phase I/II clinical trials targeting patient
groups in need of new therapies. We have initiated a Phase I/II clinical trial
that will enroll approximately 20 patients with either advanced
Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma
(ACC). In the first half of 2014, we also anticipate initiating a Phase I/II
TKM-PLK1 clinical trial that will enroll patients with Hepatocellular
Carcinoma (HCC). The data from these trials will inform our future development
and regulatory strategy for the TKM-PLK1 program, which will be led by our new
CMO, Dr. Mark Kowalski," said Dr. Mark J. Murray, Tekmira's President and CEO.

"This past quarter, Alnylam presented positive data from its ALN-TTR02
program, an RNAi therapeutic enabled by Tekmira's LNP technology. Alnylam has
guided that it anticipates starting a Phase III or pivotal trial for ALN-TTR02
by the end of 2013, which will trigger a $5 million milestone payment to us.
On the business development front, we continue to actively collaborate with a
number of companies using our technology, including pharmaceutical,
biotechnology and agricultural companies," stated Dr. Murray.

Corporate Update and Highlights

Tekmira's Products

TKM-PLK1, Tekmira's Lead Oncology Therapeutic

Tekmira's lead oncology product candidate, TKM-PLK1, targets polo-like kinase
1 (PLK1), a protein involved in tumor cell proliferation and a validated
oncology target. Inhibition of PLK1 expression prevents the tumor cell from
completing cell division, resulting in cell cycle arrest and death of the
cancer cell. PLK1 has been a target of interest for years, and evidence that
patients with elevated levels of PLK1 in their tumors exhibit poorer prognosis
and survival rates has been documented in the medical literature.

Based on the encouraging results from the Phase I TKM-PLK1 clinical trial that
were presented at the 2013 American Association for Cancer Research (AACR)
Annual Meeting, Tekmira has initiated a Phase I/II clinical trial with
TKM-PLK1, which will enroll patients with advanced Gastrointestinal
Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC).

The TKM-PLK1 GI-NET and ACC Phase I/II clinical trial will be a multi-center,
single arm, open label study designed to measure efficacy using RECIST and
tumor biomarkers for GI-NET patients, as well as to evaluate the safety,
tolerability and pharmacokinetics of TKM-PLK1. TKM-PLK1 will be administered
weekly with each four-week cycle consisting of three once-weekly doses
followed by a rest week. It is expected that approximately 20 patients with
advanced GI-NET or ACC tumors will be enrolled in this trial, with a minimum
of 10 GI-NET patients to be enrolled. Tekmira expect results from this trial
by mid-2014, and if supported by the data, to commence a pivotal trial in
GI-NET in 2014.

Tekmira will also initiate another Phase I/II clinical trial with TKM-PLK1,
enrolling patients with Hepatocellular Carcinoma (HCC) in the first half of
2014. This clinical trial will be a multi-center, open label, non-randomized,
dose escalation study designed to evaluate the safety, tolerability and
pharmacokinetics of TKM-PLK1 as well as determine the maximum tolerated dose
in HCC patients and measure the anti-tumor activity of TKM-PLK1 in HCC
patients.

TKM-Ebola, Tekmira's Collaboration with the U.S. Department of Defense

TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a
contract with the U.S. DoD's Joint Project Manager Transformational Medical
Technologies (JPM-TMT) Office under a contract valued at approximately $140
million. Tekmira's contract with the JPM-TMT was recently modified to support
development plans that integrate a more potent LNP formulation and
advancements in manufacturing technology, including lyophilization, as well as
provide for $6.9 million in additional funding. Tekmira has initiated
pre-clinical, chemistry, manufacturing and control studies that support the
use of these improvements in the TKM-Ebola program. Tekmira anticipates the
completion of these studies and a submission to the FDA in the second half of
2013 in order to support the use of the enhanced product in a Phase I clinical
trial.

New data from the TKM-Ebola program and other LNP innovations were presented
at the 15th Annual TIDES Summit: Oligonucleotide and Peptide® Therapeutics
from Research through Commercialization, which took place in Boston, MA on May
15, 2013. Some highlights include:

  o The presentation of data from a new formulation, more potent than any LNP
    currently in clinical trials, that is being incorporated into the
    TKM-Ebola program. This new TKM-Ebola LNP formulation has demonstrated
    significant increases in potency in non-human primates infected with the
    Zaire Ebola virus. At 0.5 mg/kg, 100% of the infected animals survived
    after receiving TKM-Ebola daily for seven days. The previous LNP
    formulation provided the same level of protection and 100% survival at 2
    mg/kg.
  o The development by Tekmira scientists of a lyophilized (freeze-dried) LNP
    to eliminate cold-chain requirements and facilitate use in tropical
    climates. Importantly, the lyophilized LNP formulation also provided 100%
    survival in non-human primates infected with the Zaire Ebola virus with no
    loss in potency at 0.5 mg/kg dosed daily for seven days.
  o The presentation of data from Tekmira's ongoing work on LNP formulations
    that can provide significant potency when administered subcutaneously. The
    presented data compares favorably to other published data using conjugate
    delivery systems and demonstrated that LNP administered subcutaneously in
    a rodent model can knockdown a liver target by 96% at 1.0 mg/kg with a
    single administration or 67% knockdown at 0.5 mg/kg after a single
    administration.

Other Preclinical Candidates

Tekmira is currently evaluating several preclinical candidates with potential
in diverse therapeutic areas. The Tekmira research team will continue to
generate data to support the advancement of the most promising of these
targets and expects to nominate the next product candidate for development
later in 2013.

Partners' Products

Alnylam's Products: ALN-TTR02, ALN-VSP, ALN-PCS02

Tekmira has granted a license to Alnylam Pharmaceuticals, Inc. to use
Tekmira's LNP technology to enable RNAi therapeutic products. Tekmira is
entitled to receive a $5 million milestone payment when ALN-TTR02 enters a
pivotal or Phase III clinical trial, which Alnylam has guided should occur by
the end of 2013. Tekmira is eligible to receive royalty payments based on
commercial sales of ALN-TTR02.

ALN-VSP, which is a systemically delivered RNAi therapeutic for the treatment
of advanced solid tumors with liver involvement, is enabled by Tekmira's LNP
technology. On June 21, 2013, Tekmira's manufacturing process technology was
transferred to Alnylam's partner, Ascletis Pharmaceuticals (Hangzhou) Co.,
Ltd., to enable them to produce ALN-VSP. Tekmira believes that this fulfills
the obligations in order to earn a US$5.0 million milestone from Alnylam.
However, Alnylam has demanded a declaration that Tekmira has not yet met the
obligations related to the milestone, and wishes to exercise arbitration
proceedings as provided for under the agreement. Tekmira disputes Alnylam's
position.

ALN-PCS02, which is an RNAi therapeutic to treat hypercholesterolemia or high
levels of cholesterol in the blood, is enabled by Tekmira's LNP technology.
Tekmira will receive milestone and royalty payments as these LNP-enabled
products are developed and commercialized.

Marqibo®

Marqibo, which is a liposomal formulation of the chemotherapy drug vincristine
– along with two other liposomal chemotherapy products, Alocrest and Brakiva –
were licensed from Tekmira to Talon Therapeutics, Inc. in 2006. In July 2013,
Spectrum Pharmaceuticals, Inc. acquired Talon. Spectrum is responsible for all
future development costs and future expenses of these licensed products. In
August 2012, Marqibo received accelerated approval from the FDA for the
treatment of adult patients with Philadelphia chromosome negative (Ph-) acute
lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has
progressed following two or more anti-leukemia therapies. Tekmira is entitled
to royalty payments based on Marqibo's commercial sales. Spectrum has guided
that it expects Marqibo to be launched later this year through Spectrum's
existing hematology sales force.

Senior Management Changes

Tekmira announced today that Dr. Mark Kowalski has joined Tekmira on a
full-time basis as Chief Medical Officer. He brings over 25 years of
experience in academic research and clinical settings, as well as clinical
drug development through his work at major pharmaceutical and biotechnology
companies, where he has led product development, clinical development, and
regulatory affairs.

Tekmira also disclosed that Mr. Ian Mortimer, Chief Financial Officer and
Executive Vice President, will resign from the company effective October 15,
2013. In this transition period, Mr. Mortimer will retain his responsibilities
as Chief Financial Officer and will continue to be a member of the Tekmira
executive team until October 15, 2013. A search for a new Chief Financial
Officer is underway.

"Having worked with Ian over the last five years, I see the significant and
lasting contributions he has made to Tekmira's success. I would like to thank
him for all his dedication and hard work during his tenure here. I know that I
speak on behalf of everyone at Tekmira in wishing him well," stated Dr.
Murray.

Financial Results

Net loss

The net loss for the second quarter was $3.1 million ($0.22 per common share)
as compared to a net loss of $1.9 million ($0.14 per common share) for the
second quarter of 2012. The net loss for the first half 2013 was $5.7 million
($0.40 per common share) as compared to a net loss of $5.1 million ($0.38 per
common share) for the first half of 2012.

Revenue

Revenue was $2.9 million for second quarter of 2013 as compared to $3.6
million for the second quarter of 2012.

Under a DoD contract to develop TKM-Ebola, Tekmira is being reimbursed for
costs incurred, including an allocation of overheads, and is being paid an
incentive fee. For this contract, Tekmira recorded $2.5 million in revenue in
the second quarter of 2013 and $2.5 million in second quarter of 2012.

In the second quarter of 2012, Tekmira earned a $1.0 million milestone from
Alnylam following initiation of their ALN-TTR02 Phase II human clinical trial.
ALN-TTR02 is enabled by Tekmira's LNP delivery technology.

Research, development, collaborations and contracts expenses

Research, development, collaborations and contracts expenses were $5.1 million
in the second quarter of 2013 as compared to $3.6 million in the second
quarter of 2012.

TKM-PLK1 clinical trial expenses have increased in the second quarter of 2013,
as compared to the second quarter of 2012, as patient enrolment has
accelerated. R&D salary expense has also increased as Tekmira has hired staff
in a number of areas supporting development of Tekmira's product candidates.

General and administrative

General and administrative expenses were $0.9 million in the second quarter of
2013 as compared to $2.4 million in the second quarter of 2012. Second quarter
of 2012 general and administrative expenses were higher as they included legal
fees incurred in respect of a lawsuit against Alnylam Pharmaceuticals, Inc.
and AlCana Technologies, Inc. that was settled in November 2012.

Financial guidance

Tekmira is updating the guidance provided in its 2012 Annual Report MD&A.
Based on updated projections, and considering that payment of the US$5.0
million ALN-VSP milestone is being disputed – Tekmira now expects 2013 revenue
to be in the range of $15.0 to $20.0 million and now expects year-end 2013
cash and cash equivalents to be in the range of $30.0 to $35.0 million.
Tekmira believes that current funds on hand, plus expected income, including
payments from current licensees, collaborative partners and the DoD will be
sufficient to last until mid-2015.

Conference Call Information

Tekmira will hold a conference call and webcast today (Monday, August 12,
2013) at 1:30 pm Pacific Time (4:30 pm Eastern Time) to discuss its second
quarter 2013 results and provide a corporate update. A live webcast of the
call can be accessed through the Investor section of Tekmira's website at
www.tekmirapharm.com. Or, alternatively, to dial into the conference call,
please call 914-495-8556 or 1-866-393-1607.

An archived webcast of this conference call will be available on the Tekmira
website approximately two hours after the event. Or alternatively, you may
access a replay of the conference call available until August 15, 2013 by
calling 404-537-3406 or 1-855-859-2056 and referencing conference ID 27564140.

About RNAi and Tekmira's LNP

RNAi therapeutics have the potential to treat a broad number of human diseases
by "silencing" disease causing genes. The discoverers of RNAi, a gene
silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery
technology to be effective systemically. Tekmira believes its LNP technology
represents the most widely adopted delivery technology for the systemic
delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in
multiple clinical trials by both Tekmira and its partners. Tekmira's LNP
technology (formerly referred to as stable nucleic acid-lipid particles or
SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles
that are effective in delivering RNAi therapeutics to disease sites in
numerous preclinical models. Tekmira's LNP formulations are manufactured by a
proprietary method which is robust, scalable and highly reproducible, and
LNP-based products have been reviewed by multiple FDA divisions for use in
clinical trials. LNP formulations comprise several lipid components that can
be adjusted to suit the specific application.

About Alnylam RNAi Technology

Tekmira has licenses to Alnylam RNAi intellectual property for certain siRNA
programs.

About Tekmira

Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on
advancing novel RNAi therapeutics and providing its leading lipid nanoparticle
delivery technology to pharmaceutical partners. Tekmira has been working in
the field of nucleic acid delivery for over a decade and has broad
intellectual property covering LNPs. Further information about Tekmira can be
found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.

Forward-Looking Statements and Information

This news release contains "forward-looking statements" or "forward-looking
information" within the meaning of applicable securities laws (collectively,
"forward-looking statements"). Forward-looking statements are generally
identifiable by use of the words "believes," "may," "plans," "will,"
"anticipates," "intends," "budgets," "could," "estimates," "expects,"
"forecasts," "projects" and similar expressions, and the negative of such
expressions. Forward-looking statements in this news release include
statements about Tekmira's strategy, future operations, clinical trials,
prospects and the plans of management; RNAi (ribonucleic acid interference)
product development programs; estimates of the number of clinical development
programs to be undertaken by Tekmira and its product development partners;
selection of additional product candidates; timing of release of clinical
data; the effects of Tekmira's products on the treatment of cancer, infectious
disease, and other diseases; the effects of TKM-PLK1 on the treatment of
cancer, including gastrointestinal neuroendocrine tumors (GI-NET),
adrenocortical carcinoma (ACC), and hepatocellular carcinoma (HCC); the
expected timing of the initiation of – and subsequent release of data from – a
Phase I/II clinical trial with TKM-PLK1, which will enroll patients with
advanced GI-NET or ACC tumors; the expected timing of the commencement of a
pivotal trial in GI-NET in 2014; and, the evaluation of additional indications
for Phase I/II development, including an anticipated Phase I/II clinical trial
with hepatocellular carcinoma (HCC) patients, and guidance thereon; the
modifications to the TKM-Ebola contract with the U.S. DoD's JPM-TMT office to
integrate recent advancements in LNP formulation and manufacturing technology;
the initiation of pre-clinical and chemistry, manufacturing and control
studies that support the use of the advancements in the TKM-Ebola program; the
completion of these studies and submission to the FDA to support the use of
the enhanced product in a TKM-Ebola Phase I clinical trial, and the timing
thereon; the initiation of a Phase I clinical trial for TKM-Ebola; the quantum
and timing of funding that may be provided to Tekmira pursuant to the
TKM-Ebola contract with the U.S. DoD's JPM-TMT Office; the evaluation of
preclinical candidates with data generation thereon to support target
selection; the timing and nomination of Tekmira's next product candidate for
development; Tekmira's expectations of entering into a separate cross license
agreement with AlCana, which includes anticipated milestone and royalty
payments and an expected agreement for AlCana not to compete in the RNAi field
for five years, and expected payments upon execution of the cross-license
agreement with AlCana; the quantum and timing of future milestone royalty
payments expected from the ALN-TTR02, ALN-VSP, ALN-PCS02 and other LNP-enabled
product development programs of Alnylam; the timing of an ALN-TTR02 pivotal or
Phase III clinical trial, and related payments to Tekmira; the timing of
enabling ALN-VSP to enter a clinical trial in China, and related payments to
Tekmira; licenses from Alnylam for the discovery, development and
commercialization of RNAi products directed to thirteen gene targets; the
timing of Spectrum Pharmaceuticals' launch of Marqibo; anticipated royalty
payments based on sales of Marqibo; the use of lipid nanoparticle technology
by Tekmira's licensees and expected royalty payments from commercial sales of
Tekmira's product development partners; statements about Tekmira's Unlocked
Nucleobase Analog (UNA) license with Marina, as well as milestone and royalty
payments thereon; the timing of the resignation of the Company's Chief
Financial Officer; statements with respect to revenue and expense fluctuation
and guidance; the quantum and timing of potential funding; statements about
Tekmira's cash runway extending into mid-2015 and estimated cash and cash
equivalents at the end of 2013; and estimates of the length of time Tekmira's
business will be funded by its anticipated financial resources.

With respect to the forward-looking statements contained in this news release,
Tekmira has made numerous assumptions regarding, among other things: LNP's
status as a leading RNAi delivery technology; the effectiveness of Tekmira's
products as a treatment for cancer, infectious disease, or other diseases; the
developmental milestones and approvals required to trigger funding for
TKM-Ebola from the JPM-TMT program; results in preclinical models are
indicative of the potential effect in humans; Tekmira's research and
development capabilities and resources; FDA approval with respect to
commencing clinical trials; the timing and obtaining of regulatory approvals
for Tekmira's products; the timing and results of clinical data releases and
use of LNP technology by Tekmira's development partners and licensees; the
time required to complete research and product development activities; the
timing and quantum of payments to be received under contracts with Tekmira's
partners including Alnylam, Spectrum, the DoD, and others; Tekmira's financial
position and its ability to execute on its business strategy; and Tekmira's
ability to protect its intellectual property rights and not to infringe on the
intellectual property rights of others. While Tekmira considers these
assumptions to be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social uncertainties
and contingencies.

Additionally, there are known and unknown risk factors which could cause
Tekmira's actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or
implied by the forward-looking statements contained herein. Known risk factors
include, among others: Tekmira's research and development capabilities and
resources may not meet current or expected demand; Tekmira's products may not
prove to be effective in the treatment of cancer, infectious disease, or other
diseases; Tekmira may not obtain and protect intellectual property rights, and
operate without infringing on the intellectual property rights of others;
Tekmira may face competition from other pharmaceutical or biotechnology
companies and the possibility that other organizations have made advancements
in RNAi delivery technology that Tekmira is not aware of; pre-clinical and
clinical trials may be more costly or take longer to complete than anticipated
and may not generate results that warrant future development of the tested
drug candidate; the FDA may determine that the design and planned analysis of
Tekmira's clinical trials do not adequately address the trial objectives in
support of Tekmira's regulatory submissions; the FDA may not approve the
commencement of Tekmira's planned clinical trials or approve the use of
Tekmira's products; TKM-PLK1 might not enter into Phase I/II clinical trials
in the timeframe anticipated, or at all; there may be no additional
indications for TKM-PLK1 Phase I/II development; the DoD may reduce or cancel
certain defense spending, including Tekmira's contract to develop TKM-Ebola,
or adversely modify the contract with Tekmira; the FDA may decide that
TKM-Ebola "Animal Rule" data is insufficient for approval and require
additional pre-clinical, clinical or other studies, refuse to approve
TKM-Ebola, or place restrictions on our ability to commercialize TKM-Ebola;
Tekmira may not complete the work or studies necessary for the submission of
the new LNP formulation for TKM-Ebola to the FDA in the anticipated timeframe,
or at all; the FDA may not approve the new LNP formulation for TKM-Ebola;
Tekmira may not initiate a new TKM-Ebola Phase I clinical trial in the
anticipated timeframe, or at all; expected milestone or royalty payments
related to the settlement and licensing agreement between Tekmira and Alnylam
may not be received in the quantum and on the timing currently anticipated, or
at all; additional exclusive or non-exclusive licenses from Alnylam may not be
received as anticipated, or at all; a Phase III or pivotal trial for ALN-TTR02
may not start as currently anticipated, or at all; payment of the ALN-VSP
milestone related to enabling an ALN-VSP clinical trial in China may not
happen as anticipated, or at all; the possibility that Tekmira may not enter
into a separate cross license agreement with AlCana on the terms currently
anticipated, or at all; Tekmira's development partners and licensees
conducting clinical trial, development programs and joint venture strategic
alliances may not result in expected results on a timely basis, or at all;
anticipated payments under contracts with Tekmira's collaborative partners may
not be received by Tekmira on a timely basis, or at all, or in the quantum
expected by Tekmira; UNAs may not have the effect of increasing stability or
reducing off-target effects when incorporated into RNAi drugs; Tekmira may
never develop a commercially viable product that uses UNA technology, or at
all; the possibility that Marqibo may not be accepted in the marketplace; the
possibility that Tekmira may not receive milestone and royalty payments based
on the successful development and commercialization of Spectrum's Marqibo,
Brakiva, and Alocrest product candidates; payments received from third parties
may not be sufficient to fund Tekmira's continued business plan as currently
anticipated; Tekmira may not appoint a replacement Chief Financial Officer in
the anticipated timeframe; future operating results are uncertain and likely
to fluctuate; Tekmira may not be able to raise additional financing required
to fund further research and development, clinical studies, and obtain
regulatory approvals, on commercially acceptable terms or at all; economic and
capital market conditions; Tekmira may become subject to product liability or
other legal claims for which Tekmira has made no accrual in its financial
statements; Tekmira's cash runway may not extend into mid-2015 as anticipated,
and may be substantially less than required to continue current operations;
and the possibility that Tekmira may not have sufficiently budgeted for
expenditures necessary to carry out planned activities.

A more complete discussion of the risks and uncertainties facing Tekmira
appears in Tekmira's annual report on Form 20-F for the year ended December
31, 2012 (Annual Report), which is available at www.sedar.com or at
www.sec.gov/edgar.shtml. All forward-looking statements herein are qualified
in their entirety by this cautionary statement, and Tekmira disclaims any
obligation to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or developments,
except as required by law.

CONTACT: Investors
         Jodi Regts
         Director, Investor Relations
         Phone: 604-419-3234
         Email: jregts@tekmirapharm.com
        
         Media
         David Ryan
         Longview Communications Inc.
         Phone: 416-649-8007
         Email: dryan@longviewcomms.ca

Tekmira Pharmaceuticals Logo
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement